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This is a Phase 1, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of BEAM-103 in Healthy Subjects

NCT ID: NCT07304791

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-27

Study Completion Date

2026-05-29

Brief Summary

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The purpose of this Phase I single ascending dose study is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of BEAM-103 in healthy subjects between the ages of 18 and 55. The main questions the study aims to answer are:

* Safety and tolerability of BEAM-103
* The pharmacokinetic (PK) profile and pharmacodynamic (PD) characteristics of EAM-103
* The effect of BEAM-103 on hematologic parameters
* To assess the immunogenicity of BEAM-103

Researchers will determine and establish the therapeutic window of the antibody and select optimal doses for future trials in patients.

Subjects will:

* Be asked to participate in the study for a duration of 4-5 months total
* Be asked to sign informed consent
* Be assessed for eligibility
* Provide medical and medication history
* Receive a single intravenous infusion of BEAM-103 or placebo on study Day 1 according to their assigned cohort
* Be followed up to 4 months after infusion

Detailed Description

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Conditions

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Healthy Subjects Healthy Participant Study

Keywords

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ESCAPE BEAM-103

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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BEAM-103 Drug Product

BEAM-103 is a monoclonal antibody that will be administered in single dose ascending dose cohorts as an intravenous infusion through the arm.

Group Type EXPERIMENTAL

BEAM-103

Intervention Type DRUG

• BEAM-103 is a monoclonal antibody administered as a single intravenous dose

Placebo

Normal Saline Solution will be administered as a matching place in single dose ascending dose cohorts as an intravenous infusion through the arm.

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DRUG

• The matching placebo comparator is administered as a single intravenous dose

Interventions

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BEAM-103

• BEAM-103 is a monoclonal antibody administered as a single intravenous dose

Intervention Type DRUG

Placebo Comparator

• The matching placebo comparator is administered as a single intravenous dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Ages 18 to ≤55 years
* Body mass index (BMI) of 18.5 to 25 kg/m2
* Morning neutrophil count ≥2.6 × 109 cells/L for Black/African American subjects or ≥3.5 ×109 cells/L for Caucasian/Other subjects
* Baseline hemoglobin value of ≥14 g/dL for males and ≥12 g/dL for females
* Baseline platelet count of \>150 × 109/L.
* Subjects must be in general good health without significant medical conditions (based on physical exam, electrocardiogram (ECG), and laboratory test results with no clinically significant deviations), per the investigator's assessment

Exclusion Criteria

* Known hypersensitivity to any component of the investigational medicinal product (IMP).
* Participation in another clinical trial involving treatment with an investigational agent within 90 days of informed consent is prohibited.
* Positive serum pregnancy test or breastfeeding at screening (female participants).
* Live virus vaccination within 4 weeks prior to signing informed consent.
* Any severe or uncontrolled medical condition (eg. severe asthma or severe peanut allergy) that in the opinion of the investigator would put the subject at undue medical risk or impair the ability to interpret study results.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beam Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Study Site

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Medical Information

Role: primary

Other Identifiers

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BTX-103-001

Identifier Type: -

Identifier Source: org_study_id